Case Studies


Daval International has performed studies in a variety of indications including Alzheimer's Disease, Multiple Sclerosis, Motorneurone Disease (ALS), Wound Healing and Systemic Sclerosis. These studies have yielded interesting results and have, in some cases, lead to phase II clinical trials with more clinical trials in the pipeline.


Safety

In over 2000 individuals and 150,000+ doses, AIMSPRO has never elicited a serious adverse side effect and can be used as a long-term therapy without the toxicity issues which besets many other medicines. A Serious Adverse Events warning label is not required for AIMSPRO by the MHRA.

Since 85% of late stage clinical trial failures are due to safety issues, AIMSPRO carries much less risk for investors than therapies which have not been used extensively in human beings over many years.


Alzheimer's Disease


Daval International has seen some positive responses in its privately treated Alzheimer patients and, as a result, the company decided to observe the effect of AIMSPRO® on Alzheimer’s dementia in individual case studies. The progress of 8 individuals with Alzheimers disease who were being treated with AIMSPRO®,was monitored over a 12 week treatment period. The results were encouraging and provided evidence that AIMSPRO® merits full clinical testing.

Patients were treated with AIMSPRO® every 3 days for 12 weeks. No other treatment parameters were altered, the patients continued to receive their usual medication and care package during this time.



Motorneurone Disease (ALS)


Daval observed 20 individual independent cases of patients with ALS. AIMSPRO® was administered as 1 to 3 subcutaneous injections daily and measurements of ALS specific scores were noted as well as FVC and biochemical and haematological profiles, pre and post treatment. The patient ALS specific scores stabilised whilst on treatment with AIMSPRO® and adverse events were limited to local skin reactions. No treatment-related SAE’s were recorded by any individual patient.

In a second group of individual case studies, 22 patients with ALS were treated with AIMSPRO® over a 6-month period, and their data was compared against a historical control group. An overall difference in the ALS Functional Rating Scale (ALSFRS)-R score was observed.

Wound Healing


A group of patients with chronic venous ulcers of various size and duration were treated with AIMSPRO® for 12 weeks, at a dose of 1ml every 3 days, for the purpose of assessing improving healing rates. All the patients had had ulcers present for at least 6 weeks or longer that had failed to respond to usual care. They continued to have usual care during their treatment with AIMSPRO®. All the patient VAS pain scores improved with treatment however. There were no single SAEs reported by any of the patients; three patients experienced mild, transient injection site reactions, which settled within 24 hours without treatment. Further work with a larger patient population is required to explore these results further.